Extractables & Leachables

Identify and quantify the levels of extractable and leachable substances that could be present

Catalent is the industry leader in extractables and leachables testing designed to support product development of pharmaceuticals. We offer the full range of extractables and leachables studies including:

  • Controlled Extraction
  • Formulation Compatibility
  • Leachables Methods Development and Validation
  • Extractables Methods Development and Validation
Catalent Benefits

Our experienced scientific staff specializes in identification of packaging related impurities by:

  • Gas Chromatography-Mass Spectrometry (GC-MS)
  • Liquid Chromatography-High Resolution Mass Spectrometry (HR LC-MS)
  • Nitrosamine Analysis (GC-Chemiluminescence)
  • Polynuclear Aromatic Hydrocarbon Screening (GC-MS)
  • Volatile Organic Compound Identification by Headspace (GC-MS)

We have extensive experience to support a wide range of dosage forms:

  • Parenterals (small volume and large volume)
  • Prefilled syringes
  • Orally inhaled and nasal drug product (OINDPs)
  • Sublinguals
  • Topicals
  • Transdermals
  • Ophthalmic
  • Implantable medical devices
Catalent Capabilities

Unparalleled service capabilities including:

  • Protocol design per PQRI
  • All classical extraction techniques (reflux, Soxhlet)
  • Microwave extraction
  • Accelerated solvent extraction (ASE)
  • Conditions including Macerations
  • Regulatory consulting
  • Paper-based toxicological assessments
  • Literature searches
  • Risk analysis
  • USP <87> testing ( in vitro bioreactivity)
  • Bioassay/Biosafety (genotoxicants)

In addition to mass spectrometry services (GC-MS and LC-MS), we have a full range of other chromatographic and spectroscopic services. Our inorganic laboratory (elemental impurity screening, ICP-MS and ICP-AES) and our organic spectroscopy laboratory (NMR, FTIR) are well-versed in supporting challenging extractables and leachables problems.